Transcranial Laser Therapy in the Rehabilitation of Hemiplegic Patients From Ischemic Stroke

Phase 1

Terminated

• Conditions: Hemiplegia
• Interventions: Procedure: low level laser therapy procedure

• Registration Number: NCT01308216
• Lead Sponsor: Hospital Universitario Ramon y Cajal

Brief Summary

The aim of this study is to determine the efficacy of transcranial laser therapy applied in automatic noncontact scanning mode for improving functional disability in patients with hemiplegia from ischemic stroke undergoing a rehabilitation program.

Detailed Description

Transcranial laser therapy is applied with an InGa(Al)As diode laser.The laser in automatic scanning is applied over both cerebral hemisphere during 15 sessions. Patients simultaneously performed a program of therapeutic exercises 3 days a week. Outcome measures were the Fugl-Meyer Upper Extremity scale, which assessed upper limb motor function, and the Barthel index, which assessed general functional disability.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2011-09
• Status Verified: 2011-11
• Study Completion: 2011-12
• Last Update Submitted: 2012-04-02
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Patients with hemiplegia secondary to cerebral stroke ischemic.
2. Requirement of shaving the scalp area.
3. Initiation of the TLT procedure begins between 70 and 100 days after stroke onset.
4. Informed written consent before enrolling in the study.

Exclusion Criteria

1. Hemiplegia secondary to hemorrhagic stroke.
2. Metallic brain implants.
3. Neurodegenerative disorders.
4. Bilateral motor problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial low level laser therapy	low level laser therapy procedure	Transcranial laser therapy is applied by automatic scanning over both hemispheres and the patients undergoing also a standard rehabilitation program based on therapeutic exercises.
Control	low level laser therapy procedure	The patients undergoing only a standard rehabilitation program based on therapeutic exercises.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Scale	20 minutes	The upper extremity Fugl-Meyer subscale (0-66) considers flexor and extensor synegies as well as reflex activity and coordination and is specific for grading motor impairments.

Secondary Outcome Measures

Name	Time	Method
Barthel index	10 minutes	Barthel index (0-100) is composed of 10 items and assesses activities related to clothing,nourishment,personal hygiene and transference.

Trial Locations

Locations (1)

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain